Neural Indices Associated With Relapse in Cannabis Depend... | NCT02801422

Studies
Neural Indices Associated With Relapse in Cannabis Dependence

NCT02801422

Sponsor

University of Electronic Science and Technology of China

Status

Unknown status

Last Update Posted

Oct 29, 2018Actual

Enrollment

75Estimated

Phase

Not provided

Conditions

Cannabis Dependence

Interventions

fMRI

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2016

Primary Completion Date

Mar 2019Estimated

Completion Date

Mar 2019Estimated

First Submitted Date

Jun 11, 2016

First Submission Date that Met QC Criteria

Jun 11, 2016

First Posted Date

Jun 15, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 26, 2018

Last Update Posted Date

Oct 29, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Benjamin Becker, Prof. Dr. rer. nat. Benjamin Becker, University of Electronic Science and Technology of ChinaPrincipal Investigator

Lead Sponsor

University of Electronic Science and Technology of ChinaOTHER

Collaborators

Name	Class
German Research Foundation	OTHER
University Hospital, Bonn	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this fMRI study is to investigate neural indices of relapse in cannabis dependence. The development and maintenance of drug addictions have been associated with deficits in cognitive control, craving and impaired stress regulation. Therefore, neural markers of brain processes underlying the beforementioned components will be studied. Subsequent follow-up drug use interviews will reveal associations between relapse in cannabis dependence and alterations in brain networks of cognitive control, craving and stress.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

75Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cannabis Dependence		ages 18-40	Other: fMRI
Healthy control subjects		socio-demographically matched	Other: fMRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
fMRI	Other		Cannabis Dependence Healthy control subjects

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
fMRI neural activation patterns of emotional processing	Activation patterns associated with emotion processing, emotion regulation, craving and stress are determined in addicted cannabis users compared to non-using matched control subjects	one time point = fMRI assessment after minimum 24 hours of abstinence

Secondary Outcomes

Measure	Description	Time Frame
Timeline Followback Interviews	Association between fMRI correlates and drug use during follow up preiod as predictor for relapse	one time point = 12 months after fMRI data acquisition

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cannabis Dependence
24 hours abstinence

Exclusion Criteria:

other DSM-4 diagnosis
neurological disorder

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Cannabis dependent individuals

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Benjamin Becker, PhD	Contact	+8618584070309		ben_becker@gmx.de
Kaeli Zimmermann, MSc	Contact	+49022828719704		kaeli.zimmermann@gmx.de

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Bonn	Recruiting	Bonn	North Rhine Westfalia	53127	Germany

Condition Browse Module

MeSH Terms

ID	Term
D002189	Marijuana Abuse
D016739	Behavior, Addictive
D012008	Recurrence

Ancestor Terms

ID	Term
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders
D003192	Compulsive Behavior

Browse Leaves

Not provided

Browse Branches

Not provided